Product Information:

TREVIA R2 5+100mg Tablets is a fixed-dose combination containing:

1. Tapentadol Hydrochloride 100mg – a centrally acting dual-mechanism analgesic (mu-opioid receptor agonist + norepinephrine reuptake inhibitor)
2. Rabeprazole Sodium 5mg – a proton pump inhibitor (PPI) that reduces gastric acid production

This formulation provides effective pain relief while offering gastric protection against opioid-induced acidity, dyspepsia, or ulcer risk—particularly useful in patients with sensitive stomachs or a history of acid-related disorders.

⚠️ Important Note:

Tapentadol is a Schedule H1 controlled substance in Pakistan due to its opioid properties. Use only as prescribed for short-term management of acute pain.

Uses of (TREVIA R2 5+100MG TABLETS):

1. Short-term treatment of moderate to severe acute pain (e.g., postoperative, dental, trauma-related)
2. Pain management in patients with history of gastritis, GERD, or NSAID-induced dyspepsia
3. Alternative to tramadol or traditional opioids when improved gastrointestinal tolerability is desired

Key Benefits of (TREVIA R2 5+100MG TABLETS):

1. Dual-action analgesia: Tapentadol offers potent pain relief with lower nausea/vomiting than classic opioids
2. Gastric acid suppression: Rabeprazole 5mg helps prevent/treat acid-related GI symptoms during opioid therapy
3. No active metabolites (unlike tramadol)—safer in mild hepatic impairment
4. Once- or twice-daily flexible dosing based on pain severity

How To Use (TREVIA R2 5+100MG TABLETS):

1. Take one tablet every 4–6 hours as needed for pain, with or without food.
2. Swallow whole with water—do not crush, chew, or split.
3. Maximum daily dose: Typically not exceeding 500mg tapentadol/day (i.e., 5 tablets), as directed by your physician.
4. Use the lowest effective dose for the shortest duration (usually ≤5–7 days).

When Not to Use (TREVIA R2 5+100MG TABLETS):

Do not use if you have:

1. Significant respiratory depression or acute asthma
2. Paralytic ileus or severe GI obstruction
3. Hypersensitivity to tapentadol, rabeprazole, or any excipients
4. Concurrent use of MAO inhibitors (or within 14 days)
5. Severe hepatic impairment (Child-Pugh C)

🚫 Not approved for children <18 years.

Side Effects of (TREVIA R2 5+100MG TABLETS):

Common:

1. Nausea, dizziness, headache
2. Drowsiness, dry mouth
3. Constipation (less than morphine/tramadol)
4. Abdominal discomfort, flatulence (from rabeprazole)

Less common:

1. Vomiting, fatigue, sweating
2. Diarrhea, rash

Serious (require monitoring):

1. Respiratory depression (especially with overdose or CNS depressants)
2. Serotonin syndrome (if combined with SSRIs, SNRIs, MAOIs)
3. Seizures (rare; higher risk with high doses)
4. Hypomagnesemia (with prolonged PPI use >3 months)
5. Discontinue and seek emergency help if slow/shallow breathing, confusion, hallucinations, or severe diarrhea occurs.

Dosage: (TREVIA R2 5+100MG TABLETS):

1. Adults: 1 tablet (tapentadol 100mg + rabeprazole 5mg) every 4–6 hours as needed
2. Elderly or mild hepatic/renal impairment: Start with longer intervals (e.g., every 6–8 hours)
3. Maximum daily dose: 5 tablets (500mg tapentadol + 25mg rabeprazole)
4. Duration: Short-term only (≤7 days for acute pain)

Who It’s For (TREVIA R2 5+100MG TABLETS):

Adults requiring short-term management of moderate to severe acute pain who are at risk of or prone to gastric irritation from analgesics.

Warnings & Precautions:

1. Avoid alcohol or other CNS depressants (benzodiazepines, sedatives)—↑ risk of respiratory depression
2. Use caution in elderly, COPD, or debilitated patients
3. Risk of dependence—even at prescribed doses—limit to short-term use
4. Do not discontinue abruptly after prolonged use—taper to avoid withdrawal
5. Monitor for Clostridioides difficile infection if used >3 days

Drug Interactions:

1. CNS depressants: ↑ Sedation, respiratory depression
2. SSRIs, SNRIs, MAOIs: ↑ Risk of serotonin syndrome
3. Methotrexate, digoxin: Altered absorption due to rabeprazole-induced pH changes
4. Atazanavir, rilpivirine: ↓ Absorption—avoid concomitant use
5. Always inform your doctor about all medications and supplements.

Additional Information:

Store below 30°C in a dry place, protected from light and moisture. Keep in a secure location away from children and unauthorized persons. Do not use after the expiration date. Available by prescription only in Pakistan (Schedule H1).